20 Jan
Brunel
Greater Toronto Area
Quality Manager II (Engineering)Greater Toronto Area, ONIntroductionThis position is responsible for providing expertise, quality oversight and guidance with regard to regulatory requirements and best practices related to manufacturing process equipment qualification including computerized systems validation. The candidate will participate in project workstreams, ensure proper execution of validation strategies as well as providing support for the quality processes and procedures. This individual will be working on cross-functional project teams which include members from various organizations within the company, such as Bulk Manufacturing, Manufacturing Technology, Engineering and ITS.
The ideal candidate will have a strong technical background, excellent problem-solving abilities, and a commitment to upholding Good Manufacturing Practices (GMP).Responsibilities:Provide quality oversight for manufacturing process equipment, CIP, SIP, Thermal, Utilities, HVAC qualification and computerized system validation activities pertaining to B100 licensure, start-up and lifecycle management. Review/approve validation deliverables (i.e. URS, specification documents, risk assessment, test strategies, protocols, executed raw data packages, reports, validation plans, SOPs, Equipment registration in SAP) in accordance with internal and regulatory policies.Review, assess and approve change controls, deviations and corrective plans, resulting from validation/qualification studies.As required, represent Quality Operations on project team and/or sub-teams and/or project working groups to provide direction on validation issues with respect to compliance.Responsible for maintaining validation awareness by screening and reporting on significant validation trends and changes through literature reviews, meetings,
and peer discussions within the industry.Qualifications Bachelor’s Degree in Engineering / Science or related field4+ years of experience in a GMP controlled environment/pharmaceutical industry Experience with qualification of manufacturing process equipment is required (examples of manufacturing equipment include: Isolators, Fermentors, Microfiltration and Ultrafiltration systems, Centrifuges, Microplate Readers, etc.)Experience reviewing documentation for completeness, reviewing reports and non-conformances/deviations, administrative tasks and leading meetings.Experience with computerized systems validation is requiredValidation experience from MSAT or quality side, conducting validation studies 3Biologics or vaccines experience would be a plusExperience with qualification of Delta V, Data Historian OSI PI,
and Manufacturing Execution System MES is an assetTechnical writing, effective oral and written communication skills, and strong compliance mindset.Good understanding of current and evolving regulatory requirementsStrong communication, negotiation, and interpersonal skills and teamworkGood interpersonal and influencing skills are important for a candidate’s successAbility to anticipate evolutions due to internal and external factors.Conflict resolution and problem-solving.Familiarity with strategic planning, balanced judgment and risk analysis.What We OfferWhy apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding.
We’ll get you going while you get on with the job.About UsBrunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
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